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The Demography domain (DM) is a a special-purpose domain that includes a set of essential standard variables that describe each subject in a study. Companies use different methods to distinguish sites and investigators. CDISC assumes that SITEID will always be present, with INVID and INVNAM used as necessary. Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets. 

The DM domain includes required variables that are often not directly collected on the Demography CRF. This data is populated using other sponsor sources of information.

Demographic information is collected about subjects in all clinical studies. The amount of demographic information collected will be determined by the analysis needs of the study and regulatory requirements, and may be affected by local restrictions related to data privacy. .

Example

This is an example demography CRF where the applicant collected information about a subject's race and ethnicity. The applicant collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity. Additionally, this applicant collected more details for subjects who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race. When multiple races were self reported, the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. In order to save space, some of the example permissible values are only shown in the metadata specifications.

Applicants may append a suffix to denote multiple collected races and ethnicities (e.g. RACE1, RACE2, CRACE1, CRACE2, CETHNIC1, CETHNIC2). The appended suffixes shown for the CDASH variables QNAM and QLABEL in this aCRF are only examples and are not indicative of any prescribed values that must be followed.


Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the subject's year of birth?Birth DateRecord the subject's year of birth (e.g., YYYY, a 4-digit year).DateBRTHDTCBRTHDAT



2What is the sex of the subject?SexRecord the appropriate sex (e.g., Female, Male).TextSEXSEX
(SEX) Female; Male; Unknown; Undifferentiated
3Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityRecord the participants self-report ethnicity, TextETHNICETHNIC
(ETHNIC)Hispanic or Latino; Not Hispanic or Latino; Not Reported; Unknown
4

Which of the following racial designations best describes you? (More than 1 choice is acceptable.)

RaceRecord the participant self-report race, TextRACE1-RACE6RACE SUPPDM.QVALRACE or RACE="MULTIPLE" and each Race is represented as a SUPPDM.QVAL where SUPPDM.QNAM = RACE(n)  and SUPPDM.QLABEL = Race (n) (RACE)AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN;OTHER

Section 2:  If the study participant answered: ASIAN or "BLACK OR AFRICAN AMERICAN.

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
5Which of the following racial designations best describes you? (More than 1 choice is acceptable.)RaceIf the subject answered "ASIAN" Select each value that applies.  TextCRACE05-CRACE10SUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.

ASIAN AMERICAN; ASIAN INDIAN; BANGLADESHI;  CHINESE; JAPANESE; KOREAN;



6Which of the following racial designations best describes you? (More than 1 choice is acceptable.)RaceIf the subject answered "BLACK OR AFRICAN AMERICAN".Select each value that applies.  TextCRACE11-CRACE17SUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CBACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.

AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;



This is an example SDTM dataset. This dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF. This includes RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC. DTHDTC and DTHFL are also expected to be included. For a subject who has not died, the value of variable DTHF is null. The death date may be blank if unknown. When multiple races were self reported, the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. 

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDINVNAMBRTHDTCSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1ABC123DMABC123-000100012006-10-112007-01-102006-10-112007-01-102006-10-032007-02-01

01JOHNSON, M1948-12-13MWHITENOT HISPANIC OR LATINOAProduct AAProduct A

USA
2ABC123DMABC123-000200022006-01-152006-02-282006-01-152006-02-282006-01-042006-03-26

01JOHNSON, M1955-03-22MWHITENOT HISPANIC OR LATINOBProduct BBProduct B

USA
3ABC123DMABC123-000300032006-01-162006-03-192006-01-162006-03-192006-01-022006-03-19

01JOHNSON, M1938-01-19FBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOBProduct BBProduct B

USA
4ABC123DMABC123-00040004



2006-01-072006-01-08

01JOHNSON, M1941-07-02MASIANNOT HISPANIC OR LATINO



SCREEN FAILURE
USA
5ABC123DMABC123-200120012006-02-022006-03-312006-02-022006-03-312006-01-152006-04-12

02GONZALEZ, E1950-06-23FAMERICAN INDIAN OR ALASKA NATIVENOT HISPANIC OR LATINOBProduct BBProduct B

USA
6ABC123DMABC123-200220022006-02-032006-04-052006-02-032006-04-052006-01-102006-04-25

02GONZALEZ, E1956-05-05FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERSNOT HISPANIC OR LATINOAProduct AAProduct A

USA
7ABC123DMABC123-20032003



2006-02-072006-02-08

03GONZALEZ, E1945-04-06FMULTIPLENOT HISPANIC OR LATINO



SCREEN FAILURE
USA
$warningHtml

Row 1:Shows USUBJID ABC123-0004 selected "JAPANESE" as the specific ASIAN race collected.
Row 2:Shows USUBJID ABC123-0003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected.
Rows 3-4:Show USUBJID ABC123-2003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.
$titleHtml

suppdm.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DMABC123-0004

CRACE9Collected Race 9JAPANESECRF
2ABC123DMABC123-0003

CRACE12Collected Race 12AFRICAN AMERICANCRF
3ABC123DMABC123-2003

RACE5

Race 5

WHITECRF
4ABC123DMABC123-2003

RACE1

Race 1

AMERICAN INDIAN OR ALASKA NATIVECRF
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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